Ontario Health Technology Assessment Series最新文献

{"title":"Robotic Surgical System for Radical Prostatectomy: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Prostate cancer is the second most common type of cancer in Canadian men. Radical prostatectomy is one of the treatment options available, and involves removing the prostate gland and surrounding tissues. In recent years, surgeons have begun to use robot-assisted radical prostatectomy more frequently. We aimed to determine the clinical benefits and harms of the robotic surgical system for radical prostatectomy (robot-assisted radical prostatectomy) compared with the open and laparoscopic surgical methods. We also assessed the cost-effectiveness of robot-assisted versus open radical prostatectomy in patients with clinically localized prostate cancer in Ontario.</p><p><strong>Methods: </strong>We performed a literature search and included prospective comparative studies that examined robot-assisted versus open or laparoscopic radical prostatectomy for prostate cancer. The outcomes of interest were perioperative, functional, and oncological. The quality of the body of evidence was examined according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also conducted a cost-utility analysis with a 1-year time horizon. The potential long-term benefits of robot-assisted radical prostatectomy for functional and oncological outcomes were also evaluated in a 10-year Markov model in scenario analyses. In addition, we conducted a budget impact analysis to estimate the additional costs to the provincial budget if the adoption of robot-assisted radical prostatectomy were to increase in the next 5 years. A needs assessment determined that the published literature on patient perspectives was relatively well developed, and that direct patient engagement would add relatively little new information.</p><p><strong>Results: </strong>Compared with the open approach, we found robot-assisted radical prostatectomy reduced length of stay and blood loss (moderate quality evidence) but had no difference or inconclusive results for functional and oncological outcomes (low to moderate quality evidence). Compared with laparoscopic radical prostatectomy, robot-assisted radical prostatectomy had no difference in perioperative, functional, and oncological outcomes (low to moderate quality evidence). Compared with open radical prostatectomy, our best estimates suggested that robot-assisted prostatectomy was associated with higher costs ($6,234) and a small gain in quality-adjusted life-years (QALYs) (0.0012). The best estimate of the incremental cost-effectiveness ratio (ICER) was $5.2 million per QALY gained. However, if robot-assisted radical prostatectomy were assumed to have substantially better long-term functional and oncological outcomes, the ICER might be as low as $83,921 per QALY gained. We estimated the annual budget impact to be $0.8 million to $3.4 million over the next 5 years.</p><p><strong>Conclusions: </strong>There is no high-quality evidence that robot-assisted radical pros","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 11","pages":"1-172"},"PeriodicalIF":0.0,"publicationDate":"2017-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515322/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35199984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lumbosacral Dorsal Rhizotomy for Spastic Cerebral Palsy: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Cerebral palsy, a spectrum of neuromuscular conditions caused by abnormal brain development or early damage to the brain, is the most common cause of childhood physical disability. Lumbosacral dorsal rhizotomy is a neurosurgical procedure that permanently decreases spasticity and is always followed by physical therapy. The objectives of this health technology assessment were to evaluate the clinical effectiveness, safety, cost effectiveness, and family perspectives of dorsal rhizotomy.</p><p><strong>Methods: </strong>We performed a systematic literature search until December 2015 with auto-alerts until December 2016. Search strategies were developed by medical librarians, and a single reviewer reviewed the abstracts. The health technology assessment included a clinical review based on functional outcomes, safety, and treatment satisfaction; an economic study reviewing cost-effective literature; a budget impact analysis; and interviews with families evaluating the intervention.</p><p><strong>Results: </strong>Eighty-four studies (1 meta-analysis, 5 randomized controlled studies [RCTs], 75 observational pre-post studies, and 3 case reports) were reviewed. A meta-analysis of RCTs involving dorsal rhizotomy and physical therapy versus physical therapy confirmed reduced lower-limb spasticity and increased gross motor function (4.5%, <i>P</i> = .002). Observational studies reported statistically significant improvements in gross motor function over 2 years or less (12 studies, GRADE moderate) and over more than 2 years (10 studies, GRADE moderate) as well as improvements in functional independence in the short term (10 studies, GRADE moderate) and long term (4 studies, GRADE low). Major operative complications, were infrequently reported (4 studies). Bony abnormalities and instabilities monitored radiologically in the spine (15 studies) and hip (8 studies) involved minimal or clinically insignificant changes after surgery. No studies evaluated the cost effectiveness of dorsal rhizotomy. The budget impact of funding dorsal rhizotomy for treatment of Ontario children with cerebral palsy was $1.3 million per year. Families reported perceived improvements in their children and expressed satisfaction with treatment. Ontario families reported inadequate medical information on benefits or risk to make an informed decision, enormous financial burdens, and lack rehabilitation support after surgery.</p><p><strong>Conclusions: </strong>Lumbrosacral dorsal rhizotomy and physical therapy effectively reduces lower-limb spasticity in children with spastic cerebral palsy and significantly improves their gross motor function and functional independence. Major peri-operative complications were infrequently reported. Families reported perceived improvements with dorsal rhizotomy, and surgery and post-operative rehabilitation were intensive and demanding.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 10","pages":"1-186"},"PeriodicalIF":0.0,"publicationDate":"2017-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515320/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35228446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Left Atrial Appendage Closure Device With Delivery System: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Atrial fibrillation is a common cardiac arrhythmia, and 15% to 20% of those who have experienced stroke have atrial fibrillation. Treatment options to prevent stroke in people with atrial fibrillation include pharmacological agents such as novel oral anticoagulants or nonpharmacological devices such as the left atrial appendage closure device with delivery system (LAAC device). The objectives of this health technology assessment were to assess the clinical effectiveness and cost-effectiveness of the LAAC device versus novel oral anticoagulants in patients without contraindications to oral anticoagulants and versus antiplatelet agents in patients with contraindications to oral anticoagulants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We performed a systematic review and network meta-analysis. We also conducted an economic literature review, economic evaluation, and budget impact analysis to assess the cost-effectiveness and budget impact of the LAAC device compared with novel oral anticoagulants and oral antiplatelet agents (e.g., aspirin). We also spoke with patients to better understand their preferences, perspectives, and values.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Seven randomized controlled studies met the inclusion criteria for indirect comparison. Five studies assessed the effectiveness of novel oral anticoagulants versus warfarin, and two studies compared the LAAC device with warfarin. No studies were identified that compared the LAAC device with aspirin in patients in whom oral anticoagulants were contraindicated. Using the random effects model, we found that the LAAC device was comparable to novel oral anticoagulants in reducing stroke (odds ratio [OR] 0.85; credible interval [Cr.I] 0.63-1.05). Similarly, the reduction in the risk of all-cause mortality was comparable between the LAAC device and novel oral anticoagulants (OR 0.71; Cr.I 0.49-1.22). The LAAC device was found to be superior to novel oral anticoagulants in preventing hemorrhagic stroke (OR 0.45; Cr.I 0.29-0.79), whereas novel oral anticoagulants were found to be superior to the LAAC device in preventing ischemic stroke (OR 0.67; Cr.I 0.24-1.64). The body of clinical evidence was found to be of moderate quality as assed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Results from the economic evaluation indicate that the LAAC device is cost-effective compared with aspirin in patients with contraindications to oral anticoagulants. In patients without contraindications to oral anticoagulants, we found that the LAAC device is not cost-effective compared with novel oral anticoagulants. Publicly funding the LAAC device in patients with nonvalvular atrial fibrillation with contraindications to oral anticoagulants could result in additional funding of $1.1 million to $7.7 million over the first five years. Patients interviewed reported on the impact of living with nonvalvular atrial fibrillation and were sup","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 9","pages":"1-106"},"PeriodicalIF":0.0,"publicationDate":"2017-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515321/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35199985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Early Follow-Up After Hospital Discharge on Outcomes in Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: A Systematic Review.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Transitions in care can increase patients' vulnerability to adverse events. In particular, patients admitted for heart failure or chronic obstructive pulmonary disorder (COPD) have high rates of readmission and return emergency department visits. Heart failure patients have the highest 30-day readmission rates in Canada, and COPD patients comprise the highest volume of readmissions. Combined, these two conditions account for the largest number of emergency department returns. Prompt follow-up of discharged patients has been linked with reduced rates of readmission, emergency department use, and death. This systematic review evaluated the clinical effectiveness of early follow-up, within either 7 days or 30 days after hospital discharge, compared with usual care or a different time to follow-up, in reducing readmissions, emergency department visits, and mortality in patients with heart failure or COPD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We performed a literature search to identify studies published in English up to May 25, 2016, on early follow-up after discharge from hospital in patients with heart failure or COPD. A single reviewer screened the titles and abstracts and obtained full-text articles for studies meeting the eligibility criteria. The risk of bias in the studies was evaluated according to ROBINS-I and EPOC criteria, and the quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;From a total of 3,228 unique citations, we identified 10 eligible studies: one randomized controlled trial, two nonrandomized controlled trials, and seven observational studies. Four studies were specifically on 7-day follow-up and 30-day health outcomes. The other six studies were on 30-day follow-up and more variable time to health outcomes. Follow-up was conducted by general and specialist physicians, nurses, and pharmacists in clinics, by telephone, and by home visit. Risk of bias was moderate for most of the studies. Having follow-up within either 7 days or 30 days after hospitalization for heart failure or COPD was associated with lower all-cause readmissions, emergency department visits, and mortality, even after accounting for confounders such as age, sex, socioeconomic status, and disease severity (GRADE: Very low to low). However, the evidence was inconsistent. We did not find a difference in effectiveness between studies using a 7-day versus a 30-day follow-up.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Based on low- and very low-quality evidence, follow-up within 7 days and within 30 days of discharge from hospitalization for heart failure or COPD-compared with usual care or no follow-up-were both associated with a reduced risk of all-cause readmission, emergency department visits, and mortality. Overall, there is a lack of large, methodologically robust studies specifically ","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 8","pages":"1-37"},"PeriodicalIF":0.0,"publicationDate":"2017-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466361/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35109077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcers: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>About 15% to 25% of people with diabetes will develop a foot ulcer. These wounds are often resistant to healing; therefore, people with diabetes experience lower limb amputation at about 20 times the rate of people without diabetes. If an ulcer does not heal with standard wound care, other therapeutic interventions are offered, one of which is hyperbaric oxygen therapy (HBOT). However, the effectiveness of this therapy is not clearly known. The objectives of this health technology assessment were to assess the safety, clinical effectiveness, and cost-effectiveness of standard wound care plus HBOT versus standard wound care alone for the treatment of diabetic foot ulcers. We also investigated the preferences and perspectives of people with diabetic foot ulcers through lived experience.</p><p><strong>Methods: </strong>We performed a review of the clinical and economic literature for the effectiveness and cost-effectiveness of hyperbaric oxygen therapy, as well as the budget impact of HBOT from the perspective of the Ministry of Health and Long-Term Care. We assessed the quality of the body of clinical evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. To better understand the preferences, perspectives, and values of patients with diabetic foot ulcers and their experience with HBOT, we conducted interviews and administered an online survey.</p><p><strong>Results: </strong>Seven randomized controlled trials and one nonrandomized controlled trial met the inclusion criteria. Comparing standard wound care plus HBOT with standard wound care alone, we found mixed results for major amputation rates (GRADE quality of evidence: low), a significant difference in favour of standard wound care plus HBOT on ulcers healed (GRADE quality of evidence: low), and no difference in terms of adverse events (GRADE quality of evidence: moderate). There is a large degree of uncertainty associated with the evaluation of the cost-effectiveness of standard wound care plus HBOT. However, results appear to suggest that this treatment results in lower costs and better outcomes than standard wound care alone. Funding HBOT will result in a budget impact of $4 million per year in immediate treatment costs for the Ontario Ministry of Health and Long-Term Care. This cost decreases to $0.5 million per year when downstream costs are considered. There is a substantial daily burden of care and emotional weight associated with living with diabetic foot ulcers, both of which are compounded by concern regarding possible amputation. Patients feel that HBOT is an effective treatment and reported that they were satisfied with how their ulcers healed and that this improved their quality of life.</p><p><strong>Conclusions: </strong>The evidence makes it difficult to draw any definitive conclusions on the clinical and cost effectiveness of standard wound care plus HBOT versus standard wound care alo","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 5","pages":"1-142"},"PeriodicalIF":0.0,"publicationDate":"2017-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5448854/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35054340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prostate Cancer Patient Perspectives on the Use of Information in Treatment Decision-Making: A Systematic Review and Qualitative Meta-synthesis.","authors":"Sujane Kandasamy, Ahmad Firas Khalid, Umair Majid, Meredith Vanstone","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Men with low- to intermediate-risk prostate cancer are typically asked to choose from a variety of treatment options, including active surveillance, radical prostatectomy, or brachytherapy. The Prolaris cell cycle progression test is intended to provide additional information on personal risk status to assist men with prostate cancer in their choice of treatment. To assist with assessing that new technology, this report synthesizes qualitative research on how men with prostate cancer use information to make decisions about treatment options.</p><p><strong>Methods: </strong>We performed a systematic review and qualitative meta-synthesis to retrieve and synthesize findings across primary qualitative studies that report on patient perspectives during prostate cancer treatment decision-making.</p><p><strong>Results: </strong>Of 8,610 titles and abstracts reviewed, 29 studies are included in this report. Most men diagnosed with prostate cancer express that their information-seeking pathway extends beyond the medical information received from their health care provider. They access other social resources to attain additional medical information, lived-experience information, and medical administrative information to help support their final treatment decision. Men value privacy, trust, honesty, control, power, organization, and open communication during interactions with their health care providers. They also emphasize the importance of gaining comfort with their treatment choice, having a chance to confirm their health care provider's recommendations (validation of treatment plan), and exercising their preferred level of independence in the treatment decision-making process.</p><p><strong>Conclusions: </strong>Although each prostate cancer patient is unique, studies suggest that most patients seek extensive information to help inform their treatment decisions. This may happen before, during, and after the treatment choice is made. Given the amount of information patients may access, it is important that they also establish the trustworthiness of the various types and sources of information. When information conflicts, patients may be unsure about how to proceed. Open collaboration between patients and their health care providers can help patients manage and navigate their concerns so that their values and perspectives are captured in their treatment choices.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 7","pages":"1-32"},"PeriodicalIF":0.0,"publicationDate":"2017-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5451209/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35054342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prolaris Cell Cycle Progression Test for Localized Prostate Cancer: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Prostate cancer is very common and many localized tumours are non-aggressive. Determining which cancers are aggressive is important for choosing the most appropriate treatment (e.g., surgery, radiation, active surveillance). Current clinical risk stratification is reliable in forecasting the prognosis of groups of men with similar clinical and pathologic characteristics, but there is residual uncertainty at the individual level. The Prolaris cell cycle progression (CCP) test, a genomic test that estimates how fast tumour cells are proliferating, could potentially be used to improve the accuracy of individual risk assessment. This health technology assessment sought to determine the clinical utility, economic impact, and patients' perceptions of the value of the CCP test in low- and intermediate-risk localized prostate cancer.</p><p><strong>Methods: </strong>We conducted a systematic review of the clinical and economic evidence of the CCP test in low-and intermediate-risk, localized prostate cancer. Medical and health economic databases were searched from 2010 to June or July 2016. The critical appraisal of the clinical evidence included risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also analyzed the potential budget impact of adding the CCP test into current practice, from the perspective the Ontario Ministry of Health and Long-Term Care. Finally, we conducted qualitative interviews with men with prostate cancer, on the factors that influenced their treatment decision-making.</p><p><strong>Results: </strong>For the review of clinical effectiveness, we screened 3,021 citations, and two before-after studies met our inclusion criteria. In one study, the results of the CCP test appeared to change the treatment plan (from initial to final plan) in 64.9% of cases overall (GRADE rating of the quality of evidence: Very low). In the other study, the CCP test changed the treatment received in nearly half of cases overall, compared with the initial plan (GRADE: Very low). No evidence was available on clinical outcomes of patients whose treatment was informed by CCP results. For the review of cost-effectiveness, 100 citations were identified and screened. No studies met the inclusion criteria. In our economic evaluation, we estimated that publicly funding the CCP test would result in a total net budget impact of $41.3 million in the first 5 years, mostly due to the cost of the CCP test. In our model, the relatively small cost savings ($7.3 million) due to treatment change (increased use of active surveillance and decreased use of interventional treatment) was not large enough to offset the high cost of the test. Patients viewed the test as potentially helpful but, due to the complexity of treatment decision-making, were unsure the test would ultimately change their treatment choices.</p><p><strong>Conclusions: </strong>We found no evidence to demonstr","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 6","pages":"1-75"},"PeriodicalIF":0.0,"publicationDate":"2017-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5451271/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35054341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacogenomic Testing for Psychotropic Medication Selection: A Systematic Review of the Assurex GeneSight Psychotropic Test.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>A large proportion of the Ontario population lives with a diagnosed mental illness. Nearly 5% of Ontarians have major depressive disorder, and another 5% have another type of depressive disorder, bipolar disorder, schizophrenia, anxiety, or some other disorder not otherwise specified. Medications are commonly used to treat mental illness, but choosing the right medication for each patient is challenging, and more than 40% of patients discontinue their medication within 90 days because of adverse effects or lack of response. The Assurex GeneSight Psychotropic test is a pharmacogenomic panel that provides clinicians with a report to guide medication selection that is unique to each patient based on their individual genetic profile. However, it is uncertain whether guided treatment using GeneSight is effective compared with unguided treatment (usual care).</p><p><strong>Methods: </strong>We performed a systematic review to identify English-language studies published before February 22, 2016, that compared GeneSight-guided care and usual care among people with mood disorders, anxiety, or schizophrenia. Primary outcomes of interest were prevention of suicide, remission of depression symptoms, response to depression therapy, depression score, and quality of life. Secondary outcomes of interest were impact on therapeutic decisions and patient and clinician satisfaction. Risk of bias was evaluated, and the quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group criteria.</p><p><strong>Results: </strong>Four studies met the inclusion criteria. These studies used a version of GeneSight that included the <i>CYP2D6, CYP2C19, CYP1A2, SLC6A4</i>, and <i>HTR2A</i> genes; one of the studies also included <i>CYP2C9</i>. Patients who received the GeneSight test to guide psychotropic medication selection had improved response to depression treatment, greater improvements in measures of depression, and greater patient and clinician satisfaction compared with patients who received treatment as usual. We observed no differences in rates of complete remission from depression. The findings were based on GRADE assessment of low to very low quality evidence, and the body of evidence had several limitations: the included studies used an older version of GeneSight and were limited to a population with major depression, so results may not be generalizable to other versions of the test or different populations such as patients with anxiety or schizophrenia.</p><p><strong>Conclusions: </strong>There is uncertainty about the use of GeneSight Psychotropic pharmacogenomic genetic panel to guide medication selection. It was associated with improvements in some patient outcomes, but not others. As well, our confidence in these findings is low because of limitations in the body of evidence.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 4","pages":"1-39"},"PeriodicalIF":0.0,"publicationDate":"2017-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5433545/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35004710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies.</p><p><strong>Methods: </strong>The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology.</p><p><strong>Results: </strong>Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes, and multiple mechanisms to provide feedback through routes to reporters and the wider community (local meetings, email alerts, bulletins, paper contributions, etc.).</p><p><strong>Conclusions: </strong>The design of a patient safety learning system can be optimized by an awareness of the barriers to and facilitators of successful adoption and implementation identified by health care professionals. Evaluation of the effectiveness of a patient safety learning system is needed to refine its design.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 3","pages":"1-23"},"PeriodicalIF":0.0,"publicationDate":"2017-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5357133/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34840493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Percutaneous Ventricular Assist Devices: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Percutaneous coronary intervention (PCI)-using a catheter to place a stent to keep blood vessels open-is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI.</p><p><strong>Methods: </strong>We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care.</p><p><strong>Results: </strong>Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low-very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low), bleeding (GRADE low), or vascular complications (GRADE low) in high-risk PCI and cardiogenic shock. No randomized controlled trials or prospective observational studies with a control group have studied Impella CP and Impella 5.0 (other models of the device) in patients undergoing high-risk PCI or patients with cardiogenic shock. The economic model predicted that treatment with the Impella device would have fewer quality-adjusted life-years (QALYs) and higher costs than IABP in high-risk PCI patients. These observations were consistent even when uncertainty in model inputs and parameters was considered. We estimated that adopting Impella would increase costs by $2.9 to $11.5 million per year.</p><p><strong>Conclusions: </strong>On the basis of evidence of low to very low quality, Impella 2.5 devices were associated with improved hemodynamic stability, but had mortality rates and safety profile similar to IABPs in high-risk PCI ","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"17 2","pages":"1-97"},"PeriodicalIF":0.0,"publicationDate":"2017-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5313122/pdf/ohtas-17-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34760306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}